Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

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The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.

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Layout table for eligibility information

Ages Eligible for Study:

2 Months to 18 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.

Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.

Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.

Exclusion Criteria:

Clinical manifestation of Japanese Encephalitis

History of Flavivirus vaccination (including any investigational vaccines)

History of vaccination with HAVRIX®720 and/or Prevnar®

History of immunodeficiency or immunosuppressive therapy

Known HIV, HBV or HCV infection

History of hypersensitivity reactions to other vaccines

Acute febrile infection at each visit during which the subject receives a vaccination

Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.